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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Emergency Airway
510(k) Number K853345
Device Name 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
Applicant
31st. Centruy Medical Corp.
435 Old Hickory Dr.
Pittsburgh,  PA  15235
Applicant Contact ANTHONY SERVELLO
Correspondent
31st. Centruy Medical Corp.
435 Old Hickory Dr.
Pittsburgh,  PA  15235
Correspondent Contact ANTHONY SERVELLO
Regulation Number868.5090
Classification Product Code
BWC  
Date Received08/12/1985
Decision Date 10/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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